PV Operations/Pharmacovigilance Operations/Drug & Safety Reporting/Pharma Regulatory Role

Lifesciences operations, medical devices,PV Operations/Pharmacovigilance Operations/Drug & Safety Reporting/

Job Opening for Pharma covigilance Operation, Drug & Safety reporting, profile.

Location Kolkata

Etmf, Clinical operations, pharma, lifescience domain

BPO exp current or previous is mandatory.

Good Team Management is required.

Below is detailed JD

Principal Responsibilities:

- Independently manage PV account including multiple LOBs, ~100+ FTE'

- Manage service levels for LOB and take steps for continuous improvement.

- Ensure compliance to SOW, MSA

- Prepare review decks and front end weekly/monthly/quarterly reviews

- Meet revenue and margin targets

- Lead project management for new business ramp and other new initiatives, as needed.

- Conduct weekly internal reviews with DRs and drive outlier management within the process

- Team member appraisal for DRs and ensure adherence for the team

- Capacity planning in coordination with WFM

- Manage other delivery related activities

- Ensure high CSAT for the LOB

- Drive business value for customer & continuous process improvement initiatives

- Participate in interviewing process for external interviews, IPPs and IJPs

- Act as a compliance/risk champion for the process and lead CMMI initiatives

- Work with multiple functions, i.e. Finance, Corporate Logistics, Manufacturing, Supply Chain, etc to meet Customer needs with a focus on business process improvement and customer relations

- As part of a customer team, help to marry business capabilities, processes and objectives to the customers- requirements on a global scale.

- Work with multiple functions, i.e. Finance, Corporate Logistics, Manufacturing, Supply Chain, etc to meet customer needs with a focus on business process improvement and customer relations

- Staff Motivation, Performance appraisal of team members and counseling for performance and capability building in conformance with goals

- Responsible for managing attendance, performance improvement plan and incentives for the team

- Track and analyze the top defects of the team to identify the training needs for the team

- Ensure attrition targets are met, people management, growth, retention, regular skip meetings

- Drive adherence to company policies and floor policy

- Ensure audit readiness for the account at all times

Critical Skills Required:

- Registered Pharmacist, M. Pharma/B. Pharma Preferred, Life Sciences academics is a must

- 14+ Years of industry exposure specially in the field of Healthcare & Life Sciences, such as PV, Clinical Trials, Medical writing, virtual Pharma, Pharma regulatory affairs etc.

- Exposure to Pharmacovigilance is preferred

- Knowledge of computer i.e. MS - Office and on-line tools

- Excellent Communication Skills (Verbal & Written)

- Strong interpersonal & influence management skills

- Ability to work & communicate with people across organizational units

- Ability to think strategically & translate strategy into action plans

- Strong analytical skills with an ability to solve a problem with a win-win negotiation approach

- Ability to lead people on large, multi-functional efforts, 100+ FTE- s

- Decision making skills

- Strong Team building skills

- Leading by Example and ability to handle stressful situations

- Knowledge of Client and end user requirement

- Excellent in review management, both internal and external stakeholder management